FDA Medical devices recall ·
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit recall
- Recall number
- Z-1742-2025
- Date
- (initiated March 31, 2025)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 60 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Why was it recalled?
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. SILV800-01; UDI: 10809160450680; Lot Code: Lot: 1642454; Exp: 2/4/2028.
Distribution
US Nationwide distribution in the states of IL & LA.
States: Illinois
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1742-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.